Alpine vs. Xpedition: Evaluation of Stent Delivery System (AXES)

Randomized Clinical Evaluation of Alpine® vs. Xpedition® Stent Delivery System of the XIENCE® Everolimus-eluting Stent

To evaluate and compare the performance of two stent delivery systems for percutaneous coronary intervention with everolimus-eluting stent.

Study Overview

• Status: Unknown
• Conditions: Percutaneous Coronary Intervention
• Intervention / Treatment: Device: Stent delivery with Xpedition; Device: Stent delivery with Alpine

Detailed Description

Rationale: The current gold standard for percutaneous coronary intervention (PCI) is the second generation drug-eluting stent (DES). The most commonly used DES is the everolimus-eluting stent (EES). New stent delivery systems for PCI with EES are developed to optimize strength, flexibility and pushability of the catheter. The effect on procedural time of new stent delivery systems has not yet been investigated in clinical practice.

Objective: To evaluate and compare the performance of two stent delivery systems for PCI with EES.

Study design: Randomized comparative trial with 500 patients in the University Medical Center Groningen (UMCG).

Study population: All patients undergoing PCI with EES, aged 18 years or older, will be considered for eligibility. Patients will be excluded when scheduled for chronic total occlusion (CTO) PCI or if verbal informed consent cannot be obtained.

Intervention: The first group will undergo PCI with the XIENCE EES using the Alpine stent delivery system, the second group will undergo PCI with the Xpedition stent delivery system.

Main study parameters/endpoints: The primary endpoint is the proportion of procedures with crossing time (from introduction of guidewire to stent deployment) longer than 30 minutes. Secondary endpoints include procedural time (from heparin administration to removal of catheter sheath, mins), use of additional materials, total procedural costs, radiation dose (μGym2), radiation time (mins), and contrast dose (ml).

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700 RB
    • Recruiting
    • University Medical Center Groningen
    • Contact: Pim van der Harst, Prof. Dr.; Email: p.van.der.harst@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients undergoing PCI with EES, aged 18 years or older

Exclusion Criteria:

• Chronic total occlusion (CTO) PCI
• Inability to obtain (verbal) informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Xpedition stent delivery system	Device: Stent delivery with Xpedition; Use of Xpedition stent delivery system to implant the XIENCE stent
Other: Alpine stent delivery system	Device: Stent delivery with Alpine; Use of Alpine stent delivery system to implant the XIENCE stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crossing time	Proportion of procedures with crossing time (from introduction of guidewire to stent deployment) longer than 30 minutes.	During PCI procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural time		During PCI procedure
Total procedural costs	Total cost of the materials used during the procedure (stent delivery system and additional materials) in euros.	During PCI procedure
Radiation dose		During PCI procedure
Radiation time		During PCI procedure
Contrast dose		During PCI procedure

Collaborators and Investigators

• Sponsor: University of Groningen
• Collaborators: Abbott

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Anticipated): October 5, 2019
• Study Completion (Anticipated): October 5, 2020

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2018
• Last Update Submitted That Met QC Criteria: February 23, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 201600966

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes